The Management of Diabetes in Everyday Life Program
MODEL
Improving Self-Care Decisions of Medically Underserved African-Americans With Uncontrolled Diabetes: Effectiveness of Patient-Driven Text Messaging Versus Health Coaching
2 other identifiers
interventional
646
1 country
19
Brief Summary
The overall goal of this study is to compare how well motivational messages (text messages from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes education materials (provided at the doctor's office) work to help African-American adults with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is difficult when you have diabetes, especially when patients have other medical conditions, their diabetes is uncontrolled, and when they live in an area without many primary care doctors. Many studies have show that encouraging text messages from the doctor's office and health coaches can help people take better care of themselves. But before primary care clinics around the country start trying to send texts, hire health coaches, or provide additional educational materials it is critical for them to know which approach is more likely to help. This study will assign African-American diabetics to either text messages, health coaches, or enhanced care to find out which one works better. The investigators especially want to find out if one works better for people at highest risk. Lastly, the investigators want to find out if messages or coaches help people improve their blood sugar, quality of life, and their feelings about primary care. The study will test messages, coaches, and enhanced care side by side in primary care doctors' offices. The messaging and coaching programs will give patients pretty much the same information, but in different ways. The text messages will be written carefully based on each patient's needs and interests. The coaches will be trained in how to help people get motivated and work to reach their health goals. This study will include 646 African-American adults, ages 18 and above, with uncontrolled diabetes and one or more additional chronic condition, living in medically underserved communities. People will have to have a cell phone or smart phone with texting capability and be able to use it to participate. 258 participants will get messages, 258 will get coaches, and 130 will receive enhanced care. The investigators will be able to tell if messages and coaches work by seeing if people improve their diabetes self-care decisions, and if their blood sugar, quality of life, and feelings about primary care get better. The long-term study goal is to get primary care clinics all over the country to start using motivational messages or health coaches if they work well.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Nov 2016
Longer than P75 for not_applicable diabetes-mellitus
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedOctober 10, 2019
July 1, 2019
4.2 years
October 24, 2016
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diabetes Self-Care Activities
The Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) assesses DM self-care over the previous 7 days for 7 core behaviors: smoking, diet, exercise, blood sugar testing, foot care, smoking, and medication adherence (12 items)
1 year
Secondary Outcomes (4)
Diabetes-Specific Quality of Life
1 year
Primary Care Engagement
1 year
Quality of Care
1 year
Average Blood Sugar (A1c)
1 year
Study Arms (3)
Text Messaging (TM)
EXPERIMENTALThe TM intervention will use an extensive text message library focused on 3 key behavioral areas (diet, exercise, and medication adherence). The TM intervention will incorporate supportive cognitive behavioral strategies such as goal setting, positive reinforcement, self-talk and dealing with barriers to change. Messages will encourage social interaction (social support, problem-solving, and feedback), self-monitoring of diet and exercise, diet modification, physical activity advice and prompting and basic self- regulatory skills. Messages will be tailored based on participant demographics, health literacy, and preferences.
Health Coaching (HC)
EXPERIMENTALThe HC intervention will place emphasis on the coach establishing rapport with the participant and assessing and establishing their initial goals using motivational interviewing, HC program goals, plans for future individual sessions. A written copy of personal health goals will be given to patients at the end of the first session. Coaches will aim to meet with participants for individual HC sessions bi-monthly the first 2-3 months followed by monthly for 8 - 9 months to provide information and support regarding health habits focusing sessions on areas related to patient-identified health goals, needs, and barriers to change. Sessions can occur in person or by phone based on patient preference.
Enhanced Usual Care (EC)
ACTIVE COMPARATORAll participants in all 3 study arms (TM, HC, and EC) will receive enhanced usual care. Usual care in the participating practices will be supplemented through the following key EC resources: A. Patient-focused Resources including: 1) MODEL Program Toolkit, and 2) low literacy diabetes educational materials. B. Availability of diabetes support services including: 1) peer group support sessions, 2) diabetes education, 3) MyDiabetesCenter.org resources, and 4) Diabetes Coalition education hub resources. C. Practice-focused components including: 1) practice training/continuing medical education, and 2) reporting of diabetes performance measures.
Interventions
As specified in the arm description above
As specified in the arm description above
Eligibility Criteria
You may qualify if:
- self-identified African-American adults
- diagnosis of uncontrolled diabetes (HbA1C \> 8)
- have at least one other of 13 chronic health conditions (hypertension, congestive heart failure, coronary artery disease, cardiac arrhythmias, hyperlipidemia, stroke, arthritis, asthma, cancer, chronic kidney disease, chronic obstructive pulmonary disease, depression, and osteoporosis and excluding dementia)) using the CMS ICD-9-CM-based definitions
- is receiving or will receive care at one of our identified clinical sites
- has a cell phone or smart phone with texting and voicemail capabilities
- is not planning to move from the area in the next year
- is able to provide informed consent
- is English speaking
- completes a two-week run-in period for text message and voice message use
You may not qualify if:
- inability to understand consent procedures
- Pregnant
- presence of an unstable psychiatric condition or dementia
- perceived unwillingness or inability to participate
- inability to successfully complete the text message and voice message screening test
- Plans to move from the area and change primary care physicians in the next year.
- Diagnosis of severe depression in the last six months
- Individuals with cognitive impairment will be excluded if they experience difficulty either understanding, following directions, or communicating clearly with program staff. Individuals will be excluded if they exhibit uncontrolled psychiatric symptoms and/or behaviors that may present a danger to program staff or to the study participants themselves.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Hawkins Family Medicine
Holly Springs, Mississippi, 38635, United States
Covington Pike Primary Care, Methodist Le Bonheur Healthcare
Bartlett, Tennessee, 38135, United States
Tipton Family Medicine Center
Covington, Tennessee, 38019, United States
University of Tennessee Family Practice Center
Jackson, Tennessee, 38301, United States
Eastmoreland Internal Medicine
Memphis, Tennessee, 38104, United States
Midtown Internal Medicine, Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38104, United States
Peabody Family Care, Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38104, United States
UT Methodist Physicians, Eastmoreland Endocrinology
Memphis, Tennessee, 38104, United States
Christ Community Health Services - Third Street Health Center
Memphis, Tennessee, 38109, United States
TriState Medical Group PLLC
Memphis, Tennessee, 38116-6442, United States
Motley Internal Medicine, Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38116, United States
South Internal Medicine, Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38116, United States
UT Methodist Physicians, South Endocrinology
Memphis, Tennessee, 38116, United States
PennMarc Internal Medicine, Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38119, United States
Christ Community Health Services, Broad Avenue Health Center
Memphis, Tennessee, 38122, United States
Memphis Health Center
Memphis, Tennessee, 38126, United States
Christ Community Health Center - Raleigh Health Center
Memphis, Tennessee, 38128, United States
Whitney Slade Internal Medicine, Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38128, United States
Regional One Health
Memphis, Tennessee, 38163, United States
Related Publications (4)
Bailey JE, Surbhi S, Gatwood J, Butterworth SW, Coday M, Chen M, Gutierrez ML, Shuvo SA, Brooks IM, Binkley BL, Riordan CJ, Steinberg HO, Leak CL, Breen WR Jr, Dowell SW, Tolley EA. Comparative Effectiveness of Diabetes Self-Care Interventions in African-American Adults: A Three-Arm Randomized Controlled Trial. J Gen Intern Med. 2025 Oct 20. doi: 10.1007/s11606-025-09882-z. Online ahead of print.
PMID: 41116096DERIVEDTolley EA, Surbhi S, Bailey JE. Using preliminary data and prospective power analyses for mid-stream revision of projected group and subgroup sizes in pragmatic patient-centered outcomes research. Data Brief. 2020 Nov 17;33:106529. doi: 10.1016/j.dib.2020.106529. eCollection 2020 Dec.
PMID: 33304950DERIVEDBailey JE, Surbhi S, Gatwood J, Butterworth S, Coday M, Shuvo SA, Dashputre AA, Brooks IM, Binkley BL, Riordan CJ, Steinberg HO, Gutierrez ML, Haley LE, Leak CL, Tolley EA. The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching. Contemp Clin Trials. 2020 Sep;96:106080. doi: 10.1016/j.cct.2020.106080. Epub 2020 Jul 9.
PMID: 32653539DERIVEDGatwood J, Shuvo S, Ross A, Riordan C, Smith P, Gutierrez ML, Coday M, Bailey J. The Management of Diabetes in Everyday Life (MODEL) program: development of a tailored text message intervention to improve diabetes self-care activities among underserved African-American adults. Transl Behav Med. 2020 Feb 3;10(1):204-212. doi: 10.1093/tbm/ibz024.
PMID: 30794316DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James E Bailey, MD, MPH
University of Tennessee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
November 7, 2016
Study Start
November 1, 2016
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
October 10, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
Data may be exported from the database system that houses study data in a variety of formats for sharing and/or analysis. At study completion, the investigators anticipate extracting all data from the system for sharing with other sources once appropriate governance and sharing restrictions have been addressed. Data dictionaries and associated metadata will be provided as needed upon request. Data can be shipped or mailed in approved, encrypted format or collected via SFTP (secure file transfer protocol) from our servers. The cost of allowing prospective investigators access to the de-identified data from this project will include IRB costs to review the application, salary support to cover staff time to review the concept proposal, submit documents to the IRB, and to establish password-protected and secured transfer application of the data. This cost is per application per investigator who wishes access granted to the de-identified data.